2018 ASCO Annual Meeting!
Session: Gastrointestinal (Noncolorectal) Cancer
Type: Oral Abstract Session
Time: Monday June 4, 3:00 PM to 6:00 PM
Location: Arie Crown Theater
Unicancer GI PRODIGE 24/CCTG PA.6 trial: A multicenter international randomized phase III trial of adjuvant mFOLFIRINOX versus gemcitabine (gem) in patients with resected pancreatic ductal adenocarcinomas.
Gastrointestinal (Noncolorectal) Cancer
2018 ASCO Annual Meeting
J Clin Oncol 36, 2018 (suppl; abstr LBA4001)
Author(s): Thierry Conroy, Pascal Hammel, Mohamed Hebbar, Meher Ben Abdelghani, Alice Chia-chi Wei, Jean-Luc Raoul, Laurence Chone, Eric Francois, Pascal Artru, James Joseph Biagi, Thierry Lecomte, Eric Assenat, Roger Faroux, Marc Ychou, Julien Volet, Alain Sauvanet, Claire Jouffroy-Zeller, Patrick RAT, Florence Castan, Jean-Baptiste Bachet; Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, France; Hopital Beaujon, Clichy, France; Hopital Huriez, Lille, France; Centre Paul Strauss, Strasbourg, France; Princess Margaret Cancer Centre, Toronto, ON, Canada; Institut Paoli Calmettes, Marseille, France; Centre Hospitalier Universitaire, Nancy, France; Centre Antoine-Lacassagne, Nice, France; Hopital Prive Jean Mermoz, Lyon, France; Cancer Centre SE Ontario at Kingston General Hospital, Kingston, ON, Canada; Hôpital Trousseau, Tours, France; Hôpital Saint Eloi, Montpellier, France; CHD Vendée, La Roche-Sur-Yon, France; Montpellier Cancer Institute, Montpellier, France; Centre Hospitalier de Reims Robert Debré, Reims, FR; Unicancer, Paris, France; CHU Dijon, Dijon, France; Biometrics Department, Institut du Cancer Montpellier, Montpellier, France; Hospital Pitié-Salpêtrière, Paris, FR
Background: FOLFIRINOX is more effective than gem as first-line treatment in metastatic pancreatic cancer for patients (pts) with good performance status. This trial assessed the benefit of mFOLFIRINOX in the adjuvant setting. Methods: PRODIGE 24/CCTG PA.6 is a phase III multicenter, randomized clinical trial. Pts aged 18-79 years with histologically proven pancreatic ductal adenocarcinomas, 21-84 days after R0 or R1 resection, WHO PS ≤1, adequate hematologic and renal function, and no cardiac ischemia, were eligible. Randomization was stratified by center, pN, R margin status, and post-operative CA 19-9 level (≤ 90 U/mL vs 91-180). Arm A pts received 28-day cycles of gem on days 1, 8, and 15 for 6 cycles. Arm B pts received mFOLFIRINOX (oxaliplatin 85 mg/m², leucovorin 400 mg/m², irinotecan 150 mg/m² D1, and 5-FU 2.4 g/m² over 46 h) every 14 days for 12 cycles. Primary endpoint was disease-free survival (DFS). Secondary endpoints were overall survival (OS), metastasis-free survival (MFS), and adverse events (AE). 490 pts were required to observe 342 events to show a gain in 3-year DFS from 17% to 27% (HR = 0.74) with a two-sided α = 0.05 and 80% power. Hazard ratios (HR) and 95% CI were estimated by a stratified Cox proportional hazard model. We observed 91.5% of the events required. The IDMC approved early ITT analysis before March 15, 2018. Surgical procedures, pathology and postoperative CT scans reports were centrally reviewed. Results: From Apr 2012 to Oct 2016, 493 pts were enrolled in 77 centers: Arm A/B: 246/247. With a median follow up of 30.5 months [m] (95% CI, 29.5-33.7), median DFS was 12.8 (95% CI, 11.7-15.2) in Arm A vs 21.6 m (95% CI, 17.5-26.7) in Arm B, HR = 0.59 (95% CI, 0.47-0.74). The median OS (Arm A/B) was 34.8 (95% CI, 28.6-43.8) vs 54.4 m (95% CI, 41.5- --), HR = 0.66 (95% CI, 0.49-0.89). The median MFS (Arm A/B) was 17.7 (95% CI, 14.2-21.7) vs 30.4 m (95% CI, 21.6- --), HR = 0.59 (95% CI, 0.46-0.76). Grade 3-4 AE (Arm A/B) were reported in 51.1% vs 75.5%, including 12% grade 4 in each arm, with a toxic death in Arm A. Conclusion: Adjuvant mFOLFIRINOX is safe and significantly improves DFS, MFS and OS compared to gem. Clinical trial information: NCT01526135
1. FOLFIRINOX until progression, FOLFIRINOX with maintenance treatment, or sequential treatment with gemcitabine and FOLFIRI.3 for first-line treatment of metastatic pancreatic cancer: A randomized phase II trial (PRODIGE 35-PANOPTIMOX).